Medical Device Manufacturer · US , West Sacramento , CA

Helix Diagnostics, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1991
15
Total
15
Cleared
0
Denied

Helix Diagnostics, Inc. has 15 FDA 510(k) cleared immunology devices. Based in West Sacramento, US.

Historical record: 15 cleared submissions from 1991 to 2000.

Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.

15 devices
1–12 of 15
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control · Immunology
Sep 2000 81d
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489 · LLL Extractable Antinuclear Antibody, Antigen And Control · Immunology
Apr 2000 51d
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
May 1998 104d
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K960091 · LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control · Immunology
Mar 1996 69d
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
K954700 · LKJ Antinuclear Antibody, Antigen, Control · Immunology
Dec 1995 64d
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
K954723 · LKJ Antinuclear Antibody, Antigen, Control · Immunology
Dec 1995 63d
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
K952253 · LLL Extractable Antinuclear Antibody, Antigen And Control · Immunology
Aug 1995 101d
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
K951850 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
Jul 1995 88d
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
K951798 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
Jul 1995 90d
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
K940510 · LKP Anti-sm Antibody, Antigen And Control · Immunology
Apr 1994 75d
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
K940588 · LKO Anti-rnp Antibody, Antigen And Control · Immunology
Apr 1994 71d
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850 · LLL Extractable Antinuclear Antibody, Antigen And Control · Immunology
Sep 1993 106d
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